E-Type - Early Wear of Polyethylene Liners Used in DMC
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUppsala University
About this trial
This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
Written informed consent
Eligible for a Total Hip Arthroplasty according to local guidelines and appropriate candidate for a dual mobility concept
Diagnosis: Symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement
Disqualifiers
Confirmed dementia or cognitive impairment
Unwillingness to give written informed consent
Age <18 or >75 years
Hip fracture (traumatic or pathological) in need of a Total Hip Arthroplasty
Trial design
Design model
Parallel
Treatments tested in this trial
Total Hip Arthroplasty
DeviceAll patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VEPE linerActive comparator 1 intervention
Group B: PE linerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Wear performance
To compare the in vivo wear performance of a VEPE liner versus a conventional PE liner using CT-RSA in patients undergoing total hip arthroplasty with a dual mobility cup.
Time frame
Two years postoperatively.Secondary outcomes
1
Long-term wear performance
To evaluate the in vivo wear performance of the VEPE liner versus the conventional PE liner using CT-RSA.
Time frame
Five years postoperatively.2
Cup stability
To evaluate stability of the cup by measuring degree of migration using CT-RSA.
Time frame
Two and five years postoperatively.3
Harris Hip Score
Harris Hip Score (HHS), a clinician-completed tool scored from 0 to 100, will be used to evaluate hip function, pain, and mobility after hip replacement.
Time frame
Two and five years postoperatively.4
Hip Disability and Osteoarthritis Outcome Score
The Hip Disability and Osteoarthritis Outcome Score (HOOS), a 40-item, patient-reported questionnaire, will be used to assess the participant's opinions about their hip symptoms and functional limitations.
Time frame
Two and five years postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov